BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1905766 · Received November 16, 2010

    Report

    Report Number
    2183996-2010-02365
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED HAVING UNKNOWN ELEVATED BLOOD GLUCOSE LEVEL OFTEN. PATIENT STATED BLOOD GLUCOSE LEVEL'S HIGHEST READING WAS APPROXIMATELY 500 MG/DL; TOOK CORRECTION VIA THE INFUSION DEVICE WITH NO SUCCESS. PATIENT REPORTED CHANGING THE INFUSION SET, THE INSULIN CARTRIDGE, AND THE BATTERY; STILL WITH NO SUCCESS. PATIENT STATED THEN TOOK CORRECTION WITH A PEN; WAS SUCCESSFUL. PATIENT REPORTED SHE NOTICED WHEN SHE REMOVED THE INFUSION DEVICE OUT OF THE CARRYING CASE, THE DEVICE SMELLED OF INSULIN. PATIENT STATED SHE CAN'T SEE A LEAKAGE OR WETNESS ON THE INFUSION DEVICE OR THE ACCESSORIES. PATIENT REPORTED NO KETONES. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 130-140 MG/DL. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN